UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032551
Receipt number R000037126
Scientific Title The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Date of disclosure of the study information 2018/05/11
Last modified on 2022/05/14 10:49:46

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Basic information

Public title

The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging

Acronym

The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging

Scientific Title

The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging

Scientific Title:Acronym

The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging

Region

Japan


Condition

Condition

Esophageal Cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is
1. To clarify myocardial changes (fibrosis) after radiotherapy using cardiac MRI.
2. To make early detection of radiation-induced heart disease and to apply these results to the future radiation plan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Confirm late gadolinium enhancement (myocardial fibrosis) corresponding to radiation field 6 months and 1.5 years after radiotherapy and evaluate the correlations between radiation dose and myocardial fibrosis.

Key secondary outcomes

Examine the relationships between the frequency of cardiac events and myocardial changes.
Evaluate the correlations between the results of other examinations such as electrocardiography and myocardial changes.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Between Janualy 2013 and June 2016, the subjects will undergo cardiac MRI before, 6 month after and 1.5 years after the completion of radiation therapy.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases in which there is a radical adaptation of irradiation and long-term survival could be expected.
Eastern Cooperative Oncology Group performance status, 0-1.
Normal kidney function (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2).
There is written consent of the patient.

Key exclusion criteria

Cases in which the myocardium was expected to be included in radiation field.
Other active malignancy at the start of our study.
History of mediastinal radiotherapy.
History of chemotherapy.
History of heart disease.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Rei
Middle name
Last name Umezawa

Organization

Tohoku University Hospital

Division name

Department of Radiation Oncology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7312

Email

reirei513@hotmail.com


Public contact

Name of contact person

1st name Rei
Middle name
Last name Umezawa

Organization

Tohoku University Hospital

Division name

Department of Radiation Oncology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7312

Homepage URL


Email

reirei513@hotmail.com


Sponsor or person

Institute

Department of Radiation Oncology, Tohoku University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-728-4105

Email

ec@rinri.hosp.tohoku.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 11 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

23

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2012 Year 11 Month 22 Day

Date of IRB

2012 Year 12 Month 07 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 11 Day

Last modified on

2022 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name